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New Hampshire CLIA and State Lab Requirements

The state lab license or registration, exemptions, fees and where the CMS-116 goes, with citations.

Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states

What testing sites miss in New Hampshire

Does New Hampshire require a state lab license on top of CLIA?

New Hampshire licenses laboratories that test human samples, and collection stations, as health facilities. Physicians' offices, offices of other licensed health professionals and community health clinics are exempt. CLIA-certified labs with compliance or accreditation inspections are deemed licensed, but that shortcut excludes waived and PPM labs.

  • Laboratory license (RSA 151)
  • Issued by New Hampshire Department of Health and Human Services
  • Reaches labs doing only waived tests

Citation: RSA 151:2, I(c) and II; RSA 151:5-b, II; He-P 808

Who is exempt in New Hampshire?

Physicians' offices, offices of other licensed health professionals, community health clinics, state-run sites, forensic-only labs, licensed EMS providers, hospital labs on hospital premises, and sites running waived tests only for risk assessment, not diagnosis or treatment.

Citation: RSA 151:2, II; He-P 808.02

What does New Hampshire charge?

Collecting stations: $250 (as of October 2026).

  • Waived: $150 per year for each category of testing licensed (as of October 2026)
  • PPM: $150 per year for each category of testing licensed (as of October 2026)

Citation: RSA 151:4

How often does a New Hampshire lab registration renew?

  • Renews every year
  • Due A license expires one year from issue; file the renewal application at least 120 days before it expires ($100 fine for a late renewal application).

Does New Hampshire add a form to the CMS-116?

The state license application goes to the Health Facilities Administration separately from the CMS-116, with a floor plan, written local health, building, zoning and fire approvals, a criminal records check for the owner, director and administrator, the test list and a copy of the CLIA certificate.

Where does a New Hampshire CMS-116 go?

  • New Hampshire Department of Health and Human Services, Health Facilities Administration
  • Email: CLIA@dhhs.nh.gov
  • Phone: (603) 271-9048

Opening a testing site in New Hampshire?

We prepare the CMS-116 and any New Hampshire filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.

Sources

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